Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 7:23 PM
Ignite Modification Date: 2025-12-25 @ 5:03 PM
NCT ID: NCT01087203
Description: The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Frequency Threshold: 0
Time Frame: None
Study: NCT01087203
Study Brief: A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8. None None 0 35 19 35 View
Tanezumab Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8. None None 1 38 24 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Carotid Artery Stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Atrioventricular block second degree NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Bundle branch block left NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.0 View
Abdominal distension NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal pain upper NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Gravitational oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Injection site reaction NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 14.0 View
Cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Lung infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Post procedural cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Post procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Post procedural discharge NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Sensory disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Sinus headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.0 View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Dermatitis contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Petechiae NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Rash papular NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypercholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypertriglyceridaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Joint stiffness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Plantar fasciitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Synovial cyst NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Areflexia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Burning sensation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Diabetic neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Hyperaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Hyporeflexia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Skin ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Cataract operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.0 View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Post procedural swelling NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View
Electrocardiogram ST segment elevation NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.0 View